Pradaxa Wrongful Death Lawsuit Filed Over Fatal Gastrointestinal Bleed

The family of a Tennessee woman who died after experiencing a severe gastrointestinal bleed, has filed a wrongful death lawsuit over Pradaxa against Boehringer Ingelheim, alleging that the drug maker failed to adequately warn about the risks associated with their new blood thinner.

The complaint was brought this week by Bertha Bivens, the daughter of Nancy Brummett, in the U.S. District Court for the Eastern District of Tennessee.

According to allegations raised in the lawsuit, Brummett was prescribed the relatively new blood thinner in January 2011, for long-term treatment of atrial fibrillation.

Approximately two months after the medication was prescribed, Brummett was hospitalized with a gastrointestinal bleed from Pradaxa side effects. Brummett was subsequently discharged from the hospital with hospice care and died less than three months after she first used the drug.

Pradaxa (dabigatran) is a newer anticoagulant, which was introduced by Boehringer Ingelheim in October 2010 as a superior alternative to Coumadin (warfarin) for prevention of strokes among individuals with atrial fibrillations.  It is the first of a new breed of blood thinners known as direct thrombin inhibitors, which also includes Johnson & Johnson’s Xarelto. However, there have been a staggering number of reports involving bleeding events and hemorrhages among users of Pradaxa, including hundreds of deaths.

The Pradaxa wrongful death lawsuit alleges that Boehringer Ingelheim created a defective product that is no safer than older blood thinners, and lacks a reversal agent. Coumadin (warfarin) is the blood thinner Pradaxa is meant to replace, but bleeding events with that drug can be treated with a dose of Vitamin K.

Boehringer Ingelheim should have placed a warning on Pradaxa that the drug lacks a quick way to fix bleeding events, the complaint argues. Brummett’s daughter argues that the important information was buried in small print in a medication guide under the heading of “overdose.”

Not only did the label warning fail to adequately alert doctors and patients about the Pradaxa gastrointestinal bleed risk, but the company also failed to provide any guidance on how to deal with bleeding events when they arise, the lawsuit claims.

The complaint also calls into question the “one size fits all” 150 mg formulation of Pradaxa, pointing out that Coumadin doses are sized according to a specific patients’ needs.

Brummett’s daugter indicates that the drug is defective and suggests that Boehringer Ingelheim should have issued a Pradaxa recall.

As of November 2011, Boehring Ingelheim reported there were 260 confirmed Pradaxa deaths, mostly due to bleeding problems, with 120 of those deaths reported in the U.S. The drug had only been out in the U.S. for a little more than a year, and had been available worldwide since only 2008. The FDA, European and Canadian health officials, as well as the drug company itself, have all launched investigations into Pradaxa safety risks.

The complaint is believed to be the first Pradaxa lawsuit filed in the United States, although a growing number of individuals and families throughout the United States have hired attorneys to bring claims agianst Boehringer Ingelheim in the coming months.